Evaluation Of The Efficacy Of The Combination Of Axitinib With Pemetrexed And Cisplatin In The Treatment Of Non-Squamous Non-Small Cell Lung Cancer

Phase 1/2 Completed 180 enrolled Pfizer

RandomizedSingle-groupOpen-labelTreatment

Summary

AG-013736 (axitinib) in combination with cisplatin and pemetrexed will be evaluated as first-line treatment of patients with locally advanced, recurrent, or metastatic non-squamous, non small cell lung cancer (NSCLC).

Timeline

Start: 2009-01
Primary completion: 2011-03
Completion: 2012-03

Outcome

Missed primary endpoint

registry Axitinib (Continuous) + Pemetrexed/Cisplatin (Phase 2) vs Pemetrexed/Cisplatin (Phase 2); p = 0.3037; Hazard Ratio (HR) 0.831 (95% CI 0.508 to 1.360); Log Rank NCT00768755 ↗

registry Axitinib (Modified) + Pemetrexed/Cisplatin (Phase 2) vs Pemetrexed/Cisplatin (Phase 2); p = 0.3565; Hazard Ratio (HR) 0.947 (95% CI 0.580 to 1.546); Log Rank NCT00768755 ↗

Publications

Belani CP, Yamamoto N, Bondarenko IM, Poltoratskiy A, Novello S, Tang J, Bycott P, Niethammer AG, Ingrosso A, Kim S, Scagliotti GV. Randomized phase II study of pemetrexed/cisplatin with or without axitinib for non-squamous non-small-cell lung cancer. BMC Cancer. 2014 Apr 25;14:290. doi: 10.1186/1471-2407-14-290.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Axitinib	Small molecule	10 mg	Oral
Comparator	Cisplatin	Other / unclassified	75 mg/m2	—
Comparator	Pemetrexed	Small molecule	500 mg/m2	—